17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOUAREG CloseFit UNP 2.75mmD
FDA 510(k)
FDA Class 2
·Dental
VT Sure
FDA UDI
PULMODYNE INC·00841470104962·
DISTRACTION SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036071110·
FORZA SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STA-CEPHASCREEN KIT
FDA 510(k)
FDA Class 2
·Hematology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 8, 2013
TIMESH OPTIMIZED SELF DRILLING SCREWS, 4.0 MM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code HRS·June 17, 2011
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·September 8, 2008
EVERSENSE E3 SENSOR
FDA Adverse Event
Malfunction
·SENSEONICS INC.·Product code QHJ·November 20, 2025
MPACT FLAT PE HC LINER Ø32/E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·February 19, 2016
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015